The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study

Canadian Critical Care Trials Group94 enrolled

Overview

Acute respiratory distress syndrome (ARDS) is a common and catastrophic complication of critical illness related to burns, motor vehicle accidents, or overwhelming infection. ARDS kills 40-70% of affected patients. Patients with ARDS require life support in the form of a ventilator to breathe for them while their lungs heal. Ironically, ventilators can cause further damage to the lungs. We are conducting a study comparing 2 methods to protect the lungs from further damage. One method uses standard mechanical ventilators and the other uses a new type of ventilator, called a high frequency oscillator. We propose to test whether this high frequency oscillation will reduce the relative risk of dying from ARDS. 72 patients from 12 intensive care units in Canada and Saudi Arabia will participate in this preliminary study to test the feasibility of our study methods. If feasible, we plan to move on and conduct a large multinational study to definitively answer this question.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Respiratory Distress Syndrome

Interventions

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients of either sex, 16 years and above; * Acute onset of respiratory failure, with fewer than 2 weeks of new pulmonary symptoms; * Endotracheal intubation or tracheostomy; * Hypoxaemia - defined as a PaO2/FiO2 ≤ 200 mm Hg; * Bilateral alveolar consolidation (airspace disease) seen on frontal chest radiograph Exclusion Criteria: * Remaining duration of mechanical ventilation \< 48 hours, as judged by the attending physician; * Primary cause of acute respiratory failure judged by attending physician to be cardiac in origin; * Lack of commitment to ongoing life support; * Weight \< 35 kg; * Severe chronic respiratory disease * Morbid obesity - defined as \> 1 kg / cm body height; * Neurological conditions with risk of intracranial hypertension (hypercapnia should be avoided); * Neuromuscular disease that will result in prolonged need for mechanical ventilation; * Previous enrolment in this trial; * All inclusion criteria present for \> 72 hours; * On HFO at the time of screening.

Locations (12)

University of Alberta Medical Centre

Edmonton, Alberta, Canada

Royal Columbian Hospital

New Westminster, British Columbia, Canada

St Paul's Hospital

Vancouver, British Columbia, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Hamilton Health Sciences

Hamilton, Ontario, Canada

St. Joseph's Hospital

Hamilton, Ontario, Canada

Ottawa Hospital

Ottawa, Ontario, Canada

Mt Sinai Hospital

Toronto, Ontario, Canada

St Michael's Hospital

Toronto, Ontario, Canada

Sunnybrook Health Science Centre

Toronto, Ontario, Canada

...and 2 more locations

Outcomes

Primary Outcomes

adherence to our explicit mechanical ventilation protocols;

Time frame: duration of mechanical ventilation

to measure and understand the reasons for crossovers between groups

Time frame: duration of mechanical ventilation

to estimate the rate of patient recruitment, and understand barriers to recruitment

to document our ability to achieve close to complete follow-up for mortality and quality of life in the 6 months following enrolment